Robert F. Kennedy Jr’s Confirmation and the Unexpected Turn in the Drug Pricing Debate
The Plot Thickens in Drug Pricing Drama
Just when you thought the drug pricing debate couldn't get more interesting, Robert F. Kennedy Jr adds an unexpected twist. During closed-door Senate meetings, President Trump’s US Department of Health and Human Services (HHS) Secretary nominee indicated that he’s open to seizing drug patents to lower prices. It’s a surprising position for a Republican nominee, one that traditionally aligns more with progressive policy circles.1
And, with Kennedy Jr's confirmation hearings this week (Senate Finance on January 29 and Senate HELP on January 30), the timing couldn't be more dramatic.
Why March-In Rights Matter Now More Than Ever
Let’s break down march-in rights. Established under the Bayh-Dole Act of 1980, these rights are essentially the government’s last-resort tool for controlling drug prices. The idea is simple: if taxpayers helped fund the development of a drug, the government should have a say in its pricing.2
Last year, the Biden administration revived this tool with a framework aimed at using march-in rights to address high drug prices. PhRMA, predictably, isn't thrilled. While they argue it misinterprets the law, I believe their real concern is this: it could mark the beginning of a major shift in how we handle drug pricing in America.3
A Historical Perspective on March-In Rights March-in rights were created to protect taxpayer investments in drug development. The law intended to promote the commercialization of federally-funded research while ensuring public access to its benefits. Essentially, if drugs developed with federal funding aren’t available on reasonable terms, the government can “march in” and license those patents to other manufacturers.2,3
Despite being around for 45 years, march-in rights have never been used.
Since 1980, the NIH has received 6 march-in petitions, including ones for HIV/AIDS drugs and prostate cancer treatment Xtandi, but denied all of them. Xtandi, developed at the University of California, Los Angeles (UCLA) with NIH grants, costs patients in the US around $189 800 annually—nearly 3 times the cost that patients pay in other countries.5
Is the Innovation Pipeline at Risk?
The reach of march-in rights could be substantial. A 2022 study in Health Affairs found that NIH funding contributed to research associated with every new drug approved by the US Food and Drug Administration (FDA) from 2010 to 2019, or more than 350 total drugs.6 This includes treatments for:
- Cancer (Keytruda, Ibrance)
- Multiple sclerosis (Ocrevus)
- Diabetes (Ozempic)
- HIV (Biktarvy)
Interestingly, several drugs selected for Medicare price negotiations have ties to federal funding. Of the 15 drugs recently selected for 2027 price negotiations, at least 3 benefited from NIH-funded research in their development phases. These drugs could theoretically face march-in actions, though the pharmaceutical industry argues this uncertainty could freeze future development.7
Current Policy Momentum
The Biden administration's framework for using march-in rights, released in December 2023, suggests price could be considered when determining whether a drug is "reasonably available." This interpretation faces strong industry opposition, with PhRMA arguing it misreads the original statute.8
Theoretically, HHS would likely mimic the parameters of the Medicare Drug Price Negotiation program and focus on single source drugs without generic or biosimilar alternatives.
Practical Implications and Challenges
Implementing march-in rights brings up complex questions, including:
• How do we define “reasonable” pricing?
• What impact will this have on future government-industry research partnerships?
• Will patent law and constitutional challenges arise?
• Does the administration have the capacity to evaluate and execute march-in petitions?
Looking Forward (Perpetually)
As I tune into RFK Jr’s confirmation hearings today and tomorrow (Senate Finance on January 29 and Senate HELP on January 30), I’ll be listening for his position on march-in rights, which could indicate a broader shift in drug pricing policy. With the convergence of Medicare drug price negotiations, the potential use of march-in rights, and evolving political dynamics, it’s becoming clear that 2025 will be a turning point for drug pricing reform.
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References
1. Cai S, Cancryn A. RFK Jr. says he's open to seizing drug patents. POLITICO. January 27, 2025. Accessed January 28, 2025. https://www.politico.com/news/2025/01/27/rfk-jr-health-drug-pricing-00200830
2. Constitutional challenges to the Medicare Drug Price Negotiation Program. Congressional Research Service. Updated October 10, 2024. Accessed January 28, 2025. https://crsreports.congress.gov/product/pdf/R/R47682
3. Bayh-Dole Act, 35 USC §§ 200-212 (1980).
4. March-in rights under the Bayh-Dole Act. Congressional Research Service. August 22, 2016. Accessed January 28, 2025. https://crsreports.congress.gov/product/pdf/R/R44597
5. NIH declines to ‘march-in’ on cancer drug, NIST releases new Bayh-Dole regulations. AAMC. March 24, 2023. Accessed January 28, 2025. https://www.aamc.org/advocacy-policy/washington-highlights/nih-declines-march-cancer-drug-nist-releases-new-bayh-dole-regulations
6. Galkina Cleary E, Jackson MJ, Zhou EW, Ledley FD. Comparison of research spending on new drug approvals by the National Institutes of Health vs the Pharmaceutical Industry, 2010-2019. JAMA Health Forum. 2023.4(4):e230511. doi: 10.1001/jamahealthforum.2023.0511
7. Medicare Drug Price Negotiation Program: selected drugs for initial price applicability year 2027. CMS. May 2024. Accessed January 28, 2025. https://www.cms.gov/files/document/factsheet-medicare-negotiation-selected-drug-list-ipay-2027.pdf
8. Request for information regarding the draft interagency guidance framework for considering the exercise of march-in rights. US Department of Commerce. Published December 8, 2023. Accessed January 29, 2025. https://public-inspection.federalregister.gov/2023-26930.pdf
